Intravascular VolumeNCT01388998
Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein
A study testing Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein in people with Intravascular Volume and Respiratory Changes, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intravascular Volume, Respiratory Changes
- What is being tested?
- Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line
Who cannot join
- pregnancy
- cardiac insufficiency (NYHA 4, EF < 25 %)
- coronary (CCS 4)
- coagulopathy
- symptoms of infection or sepsis
- malignant hyperthermia
Show all 9Show fewer
- porphyria
- oesophageal varicose veins
- absence of sinus rhythm
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Mainz, 55131
About this study
Official title: External Pressure Applied on the Caval Vein and Its Effects on Difference in Pulse Pressure (dPP) and Pleth Variability Index (PVI)
Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid management approach to avoid both hypervolemia and hypovolemia. However, several clinical factors may impede dPP measurements. Surgical manipulations in abdominal procedures may interfere with hemodynamic stability due to obstruction of the caval vein. Physiological considerations make us hypothesize that only intense pressure impedes caval blood flow and thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval vein.
- Conditions
- Intravascular Volume, Respiratory Changes
- Being tested
- Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein
- Keywords
- fluid management, fluid therapy, dPP, difference in pulse pressure, PVI, pleth variability index, external pressure applied on the caval vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval veinOther
Following hepatic resection, a fitting area for pressure application on the caval vein will be identified by the attending surgeon. Baseline assessments of hemodynamic and heart-lung interaction parameters will be taken. Thereafter the surgeon will apply three different pressure levels (2 N, 5 N, 10 N) at random with a force gauge (Fa. ATP Messtechnik, Ettenheim, Germany). Assessment of the parameters will be performed after 2 minutes of pressure application by an investigator, unaware of the pressure applied. After each pressure application 5 minutes will be waited to assure hemodynamic recovery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of dPP from start of intervention to 2 minutes after start of the intervention
Measured: Application of pressure for 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular VolumeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia T. Strys, Johannes Gutenberg University Mainz
- Investigators
- Lydia T. Strys, MD, Principal investigator, Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)Dorothea Closhen, MD, PhD, Principal investigator, Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)Gunther Pestel, MD, PhD, Study director, Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388998
- Sponsor's protocol ID
- 837.308.10(7317)
- Status last verified
- Apr 2012
- First submitted
- 5 Jul 2011
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Pressure Applied on the Caval Vein and Its Effects on Difference in Pulse Pressure (dPP) and Pleth Variability Index (PVI)
- ClinicalTrials.gov ID
- NCT01388998
- Acronym / sponsor ID
- 837.308.10(7317)
- Conditions
- Intravascular Volume, Respiratory Changes
- Keywords
- fluid management, fluid therapy, dPP, difference in pulse pressure, PVI, pleth variability index, external pressure applied on the caval vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid management approach to avoid both hypervolemia and hypovolemia. However, several clinical factors may impede dPP measurements. Surgical manipulations in abdominal procedures may interfere with hemodynamic stability due to obstruction of the caval vein. Physiological considerations make us hypothesize that only intense pressure impedes caval blood flow and thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval vein.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line
Key exclusion criteria (9 listed)
- pregnancy
- cardiac insufficiency (NYHA 4, EF < 25 %)
- coronary (CCS 4)
- coagulopathy
- symptoms of infection or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval veinFollowing hepatic resection, a fitting area for pressure application on the caval vein will be identified by the attending surgeon. Baseline assessments of hemodynamic and heart-lung interaction parameters will be taken. Thereafter the surgeon will apply three different pressure levels (2 N, 5 N, 10 N) at random with a force gauge (Fa. ATP Messtechnik, Ettenheim, Germany). Assessment of the parameters will be performed after 2 minutes of pressure application by an investigator, unaware of the pressure applied. After each pressure application 5 minutes will be waited to assure hemodynamic recovery. | Other | – |
Primary outcome
Change of dPP from start of intervention to 2 minutes after start of the intervention
Time frame: Application of pressure for 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia T. Strys, MD principal investigator
Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Dorothea Closhen, MD, PhD principal investigator
Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Gunther Pestel, MD, PhD study director
Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein in people with Intravascular Volume and Respiratory Changes, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of dPP from start of intervention to 2 minutes after start of the intervention (time frame: Application of pressure for 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.